MAUDE Adverse Event Report: EXACTECH, INC. SMALL GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-35-01

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/10/2023

Event Type  Injury  

Event Description

As reported, approximately 3 month post op initial tsa, this 68 y/o female patient was revised due to aseptic glenoid loosening.Patient had a glenoid graft/component loosening.The case report form indicates this event is not related to devices, but is related to the procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.320-36-00 - 36mm humeral liner +0 unconstrained.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-35-01 - small glenoid plate.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of an insufficient bond between the glenoid and the bone which led to aseptic (non-infected) glenoid loosening.The extent and root cause of the reverse glenoid loosening could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.Section h11: *the following sections have corrected information: (h6) component code: 4756, appropriate component term/code not available.

• Brand Name: SMALL GLENOID PLATE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16987394
• MDR Text Key: 315792448
• Report Number: 1038671-2023-01090
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White